Clinical Research Details
Title:
Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA Trial)
Purpose:
The CABANA trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation. The CABANA trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for reducing total mortality in patients with untreated or incompletely treated atrial fibrillation.
Study Number:
202146091609
Number of Patients:
3000
Elgibility:
The intent of the CABANA trial is to enroll patients who have new onset or under-treated paroxysmal, persistent or longstanding persistent atrial fibrillation and who warrant therapy for their arrhythmia.
Patients must:
1. Have the capacity to understand and sign an informed consent form.
2. Be >18 years of age.
3. Have documented atrial fibrillation episodes >one hour in duration with >two episodes over four months with electrocardiographic documentation of one episode or at least one episode of atrial fibrillation lasting more than one week.
4. Warrant active therapy beyond simple ongoing observation.
5. Be eligible for catheter ablation and >two sequential rhythm control and/or >three rate control drugs.
6. Be >65 years of age or <65 years with one or more of the following risk factors for stroke: Hypertension defined as a BP >140/90 mmHg [93], diabetes defined as a fasting glucose >126 mg/dl [94], congestive heart failure (including systolic or diastolic heart failure), prior stroke or TIA, LA size >5.0 cm (or volume index > 40 cc/m2) or EF <35. Subjects <65 years of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify.
Treatment:
You will be assigned to one of two treatment groups by chance. 1,500 participants will be assigned catheter ablation, and the remaining 1,500 participants will be assigned drug therapy. Neither you nor your physician will be able to decide to which group you are assigned.
Principal Investigator:
Enrollment Phone:
(708) 216-2644